Non-sliding soft anchor

ABSTRACT

A method for coupling tissue includes aligning a guide tool on an outer surface of a first tissue; forming a bore in the first tissue aligned with the guide tool; deploying a non-slip suture construct through the guide tool and into the bore; adjusting a saddle along a flexible member to a position adjacent to a soft anchor, wherein the saddle prevents the flexible member from slideably moving relative to the soft anchor; and threading the flexible member through a second tissue to secure the second tissue to the first tissue.

FIELD

The present disclosure relates to an apparatus and method for coupling afirst tissue to a second tissue, such as coupling soft tissue to bone.

BACKGROUND

The statements in this section merely provide background informationrelated to the present disclosure and may not constitute prior art.

Arthroscopic procedures often include sutures and anchors to secure softtissue to bone. Despite their widespread use, sutures and sutureanchors, as well as methods for their use, can be improved. For example,tying knots in sutures may be very time consuming and difficult leperform, particularly inside the joint space. As a result, the cost ofthe procedure may be increased and the capacity of the surgeon may belimited. Furthermore, the strength of the repair may be limited by thestrength of the knot.

Another, more specific example of an area for improvement, is in thearea of rotator cuff repair. During rotator cuff repair, the sutureanchor is inserted within the bone, and the sutures are threaded throughthe tissue and tied on top of the tissue to secure the placement of thetissue relative to the bone. When placing the knot in the suture,doctors and surgeons must be aware of the potential for tissuestrangulation in the area of the knot.

The method and apparatus disclosed herein addresses these issues andnumerous others.

SUMMARY

This section provides a general summary of the disclosure, and is not acomprehensive disclosure of its full scope or all of its features.

The present disclosure provides for a non-slip suture construct forcoupling tissue. The non-slip suture construct includes a flexiblemember having a first end and a second end opposite to the first end. Asoft anchor is slideably received on the flexible member. and a saddledefines an adjustable loop. The first end of the flexible member ispassed through the soft anchor and saddle to define the adjustable loop.The flexible member is tensioned to compress the saddle, reduce a sizeof the adjustable loop, and deform the soft anchor from a first state toa second state. The saddle maintains tension on the soft anchor andretains the soft anchor in the second state and slideably fixed relativeto the suture.

The present disclosure provides for a system for implanting a non-slipsuture construct for coupling tissue. The system includes an insertiontool having a handle and a rod extending from the handle. The rodincludes a channel and a plurality of peaks on a distal end opposite thehandle. A flexible anchor of the non-slip suture construct has a firstend and a second end opposite to the first end. The flexible anchordefines a passageway extending from a first opening to a second opening,and the flexible anchor is retained in the channel between the pluralityof peaks. A suture includes a first end and a second end. The suture isslideably threaded through the passageway defined by the flexibleanchor, and the first end and the second end of the suture retained inthe handle of the insertion tool. A saddle is defined by the suture andhas a passage extending from a third opening to a fourth opening. Thehandle is configured to retain the suture. The non-slip suture constructis configured such that the saddle is configured to maintain tension onthe flexible anchor and retains the flexible anchor in a deformed stateand slideably fixed relative to the suture.

The present disclosure provides for a method for coupling tissueincluding aligning a guide tool on an outer surface of a first tissue;forming a bore in the first tissue aligned with the guide tool;deploying a non-slip suture construct through the guide tool and intothe bore; adjusting a saddle along a flexible member to a positionadjacent to a soft anchor, wherein the saddle prevents the flexiblemember from slideably moving relative to the soft anchor; and threadingthe flexible member through a second tissue to secure the second tissueto the first tissue.

The present disclosure provides for a method for coupling tissueincluding forming a bore in a bone; deploying a soft anchor of a sutureconstruct into the bore, wherein the suture construct includes aflexible member having a first portion and a second portion, the softanchor positioned between the first portion and the second portion, anda saddle positioned on the first portion; tensioning the second portionto draw the flexible member through the soft anchor and the saddle to aposition adjacent to the soft anchor, wherein the saddle compresses thesoft anchor within the bore, deforming the soft anchor and preventingthe flexible member from slideably moving relative to the soft anchor;and threading the flexible member through a soft tissue to secure thesoft tissue to the bone.

The present disclosure provides for a method for coupling tissueincluding forming a bore in a humerus; deploying a soft anchor of a non-slip suture construct into the bore; adjusting a saddle of the non-slipsuture construct along a flexible member to a position adjacent to thesoft anchor and locking the flexible member from slideably movingrelative to the soft anchor; threading the flexible member around orthrough a rotator cuff to draw the rotator cuff to the humerus;tensioning the flexible member on a top side of the rotator cuff;affixing the tensioned flexible member to a lateral row anchor to securethe rotator cuff to the humerus; and forming a web of knotless non-slipsuture constructs on the top side of the rotator cuff by inserting aplurality of non-slip suture constructs along a medial row, threading aplurality of flexible members through the rotator cuff, and affixing theplurality of flexible members to at least one lateral row anchor.

Further areas of applicability will become apparent from the descriptionprovided herein. The description and specific examples in this summaryare intended for purposes of illustration only and are not intended tolimit the scope of the present disclosure.

DRAWINGS

The drawings described herein are for illustration purposes only and arenot intended to limit the scope of the present disclosure in any way.

FIG. 1 is a prior art example of current rotator cuff repair techniques;

FIG. 2 is a perspective view of an example embodiment of a sutureconstruct according to the present disclosure;

FIG. 3 is a perspective view of another example embodiment of the sutureconstruct according to the present disclosure;

FIGS. 4A-4B are perspective views of another example embodiment of thesuture construct according to the present disclosure;

FIG. 5 is a perspective view of another example embodiment of the sutureconstruct according to the present disclosure;

FIG. 6 is a perspective view of an insertion tool for inserting one ofthe suture constructs of FIGS. 2-5 into a tissue according to thepresent disclosure;

FIG. 7 is an environmental view of an insertion guide tool positioned ata desired angle and location on a bone;

FIG. 8 is an environmental view of the insertion guide tool of FIG. 7and a bore formation tool creating a bore in the bone;

FIGS. 9-10 are environmental views of the insertion tool of FIG. 6 andthe insertion guide tool of FIG. 7 deploying one of the sutureconstructs of FIGS. 2-5 in the bore in the bone;

FIG. 11 is an environmental view of the insertion tool of FIG. 6releasing the suture constructs of FIGS. 2-5;

FIGS. 12-13 are environmental views of one of the suture constructs ofFIGS. 2-5 in the bore in the bone;

FIG. 14 is an environmental view of a plurality of the suture constructsof FIGS. 2-5 in a rotator cuff;

FIG. 15 is an environmental view of suture ends of a plurality of thesuture constructs of FIGS. 2-5 threaded through soft tissue;

FIGS. 16A-16B are perspective views of the suture ends of FIG. 15threaded onto a secondary anchor insertion tool;

FIG. 17 is an environmental view of the secondary anchor insertion toolsetting a secondary anchor in the rotator cuff of FIG. 14; and

FIG. 18 is an environmental view of the plurality of the sutureconstructs set within the rotator cuff and forming a webbed portion overthe soft tissue.

Corresponding reference numerals indicate corresponding parts throughoutthe several views of the drawings.

DETAILED DESCRIPTION

The following description is merely exemplary in nature and is notintended to limit the present disclosure, application, or uses. Itshould be understood that throughout the drawings, correspondingreference numerals indicate like or corresponding parts and features.

Traditional methods of securing two portions of tissue, for example softtissue (or muscle) to bone in rotator cuff repair as shown in prior artFIG. 1, involve the use of anchors threaded on suture strands 14 anddeployed within a humerus bone 18. Initially, a bore 22 is formed in thehumerus 18. The anchor is deployed in the bore 22 in the bone 18 tosecure the anchor. While the anchor is secured within the bore 22, thesuture strands 14 may still slide relative to the anchor. Ends 26 of thesuture strands 14 are threaded through a portion of a soft tissue 30 andtied into a knot 32 on a top side of the tissue 30 opposite a side ofthe tissue 30 adjacent to the bone 18 to secure the placement of thetissue 30 relative to the bone 18 and to keep the suture ends 26 fromsliding relative to the anchor. The suture ends 26 are then tied off tosecondary anchors 34 fixed within the humerus 18, forming a webbedportion 38 over the tissue 30 and securing the tissue 30 to the bone 18.

In other words, the suture ends 26 extend from the anchor in the bore22, through the soft tissue 30, and are tied in the knot 32 on top ofthe soft tissue 30 directly above the bore 22 in the bone 18, asillustrated in FIG. 1. The suture ends 26 are knotted on the top side ofthe soft tissue 30 to fix the suture 14 relative to the anchor toprevent the suture ends 26 from sliding relative to the anchor in thehumerus 18. Without forming the knot 32, the suture ends 26 may moverelative to the anchor in the humerus 18. The suture ends 26 extend fromthe knot 32 to the secondary anchors 34 fixed within the bone 18 and aretied off to the secondary anchors 34. This procedure is described in“JuggerKnot Soft Anchor: Arthroscopic and Mini-Open Rotator Cuff RepairUsing JuggerKnot Soft Anchor—2.9 mm with ALLthread Knotless AnchorSurgical Technique,” a publication produced by Biomet Sports Medicineand incorporated herein in its entirety. This disclosed method, whileovercoming many hurdles in price, ease of use, and others, stillcontains room for improvement. For example, the ability to quicklyinstall the soft anchors and thread the suture ends through the tissuewill always be an area for improvement. The present disclosure strivesto address these areas and others to create a more efficient sutureconstruct for joining two portions of tissue, specifically for joiningsoft tissue to bone.

With general reference to FIGS. 2-5 and specific reference to FIG. 2, anon-sliding suture construct 100 incorporating a soft anchor 104 and asaddle, or passage portion, 108 is illustrated. The non-sliding sutureconstruct 100 generally includes the soft anchor 104 connected to aflexible member, or suture, 112 having a first portion 116 adjacent to afirst end 120 and a second portion 124 adjacent to a second end 128which is opposite the first end 120. The saddle, or passage portion, 108may be positioned between the first portion 116 and the second portion124. The suture 112, saddle 108, and soft anchor 104 can be made of anyflexible material or member, and need not be made of a suture. Thesuture 112, saddle 108, and soft anchor 104 can be made of the same ordifferent materials. When the suture 112, saddle 108, and soft anchor104 are made of sutures, any suitable suture can be used. For example, abraided hollow-core suture can be used. The braided suture can include afirst end and a second end with an outer wall that defines a passagetherethrough.

Any suitable braided suture can be used such as any of the braidedsutures disclosed in U.S. patent application Ser. No. 12/915,962 titledMethod and Apparatus for Securing Soft Tissue to Bone, which was filedon Oct. 29, 2010, published as Publication No. 2011/0098727 on Apr. 28,2011, and is assigned to Biomet Sports Medicine, LLC, The entiredisclosure of the Ser. No. 12/915,962 Application is incorporated hereinby reference. To help distinguish between the suture 112, saddle 108,and soft anchor 104, or to distinguish between the first portion 116 andthe second portion 124, which can be particularly helpful for a surgeonduring surgery, the suture 112, saddle 108, soft anchor 104, firstportion 116, and second portion 124 can be provided with an identifyingcharacteristic such as different colors or designs, for example and asfurther described below. The suture 112 may be any suitable length, suchas, for example, about thirty -eight (38) inches.

As illustrated in FIGS. 2-5, the saddle 108 may be an integral portionof the suture 112 and may be proximate to one of the first end 120 andsecond end 128. While the saddle 108 is illustrated as being proximateto the second end 128, it may alternatively be proximate to the firstend 120 or at any suitable position therebetween. In an exampleembodiment, the suture 112 defines an elongated passage 132 extendingalong at least a portion of the suture 112. If the suture 112 is abraided hollow-core suture, the passage 132 can extend from the firstend 120 to the second end 128 of the suture 112. The saddle, or passageportion, 108 can be formed by a portion 108 of the passage 132 thatexits through an outer wall of the suture 112 at a first opening 136 anda second opening 140 at opposite ends of the passage portion 108. Thesecond opening 140 is closer to the second end 128 of the suture 112than the first opening 136. The second opening 140 is spaced apart fromthe second end 128. The first end 120 and first portion 116 may bepassed through the first opening 136 along the passage 132, extendthrough the passage 132, and out the second opening 140 to define anadjustable loop 142 in the suture construct 100.

The soft anchor 104 may be a flexible anchor slideably positioned at anysuitable position between the first end 120 and the second end 128 ofthe suture 112, such as about halfway between the first end 120 and thesecond end 128. The soft anchor 104 is preferably positioned between thefirst end 120 and the saddle 108 when the saddle 108 is proximate to thesecond end 128 and between the second end 128 and the saddle 108 whenthe saddle 108 is proximate to the first end 120. The soft anchor 104may also be positioned on the adjustable loop 142. The soft anchor 104can be an elongate member having a sleeve or tubular configuration witha first anchor end 144 and a second anchor end 148 opposite the firstanchor end 144. An internal passage 152 is defined by a wall of the softanchor 104 and extends between the first anchor end 144 and the secondanchor end 148. In some embodiments, the internal passage 152 extendsfrom the first anchor end 144 to the second anchor end 148. In otherembodiments, the internal passage 152 extends from a first anchoropening 156 at a location proximate to, but spaced apart from, the firstanchor end 144 to a second anchor opening 160 at a location proximateto, but spaced apart from, the second anchor end 148. The soft anchor104 can be made of resorbable or non-resorbable materials, includingbraided suture, sponges and sponge-like materials in solid form,perforated materials, woven/braided from biocompatible materials orfibers, such as, for example, polymer, polyester, polyethylene, cotton,silk, or other natural or synthetic materials.

The soft anchor 104 can have properties that allow the soft anchor 104to change shape. In this regard, the soft anchor 104 can be, forexample, compliant, flexible, foldable, squashable, squeezable,deformable, limp, flaccid, elastic, low-modulus, soft, spongy, orperforated, or have any other characteristic property that allows it tochange shape. In some aspects, the soft anchor 104 can be coated withbiological or biocompatible coatings and also can be soaked in plateletsand other biologics, which can be easily absorbed by the soft anchor104. In one embodiment, the soft anchor 104 can be formed from a strandof No. 5 braided polyester suture. In other words, multiple fibers canbe braided together to form a hollow-core braided suture having alongitudinal passage.

When the saddle 108 is proximate to the second end 128, the first end120 of the suture 112 can be passed through the second anchor opening160, guided into and along the internal passage 152, and passed out ofthe internal passage 152 through the first anchor opening 156 definingthe adjustable loop 142. When the saddle 108 is proximate to the firstend 120, the second end 128 of the suture 112 can be passed through thefirst anchor opening 156, guided into and along the internal passage 152and through the second anchor opening 160 defining the adjustable loop142. The first and second anchor openings 156, 160 can be apertures orvoids in the woven fabric of the soft anchor 104, such that the firstand the second anchor openings 156, 160 do not disrupt or break theweave of the soft anchor 104 between the first and the second anchorends 144, 148. The corresponding first and second anchor openings 156,160 can define leg or tail portions 164 that can provide additionalresistance for securing the soft anchor 104 relative to the bone. Thesoft anchor 104 described in the present disclosure may be the same asor similar to the anchor described in U.S. Patent Publication No.2013/0144338, published on Jun. 6, 2013 and assigned to Biomet SportsMedicine, LLC, which is incorporated herein by reference.

When assembled, the suture construct 100 is a non-sliding sutureconstruct. The soft anchor 104 and saddle 108 are positioned on thesuture 112 such that the anchor 104 and saddle 108 are slideably movablealong the suture 112. The first end 120 is pulled to tighten the suture112 and reduce the size of the adjustable loop 142. As the size of theadjustable loop 142 decreases, second anchor end 148 abuts first opening136 in saddle 108 and compresses soft anchor 104 such that the softanchor 104 deforms. The first portion 116 that is fed through the secondportion 124 to form the saddle 108 exerts a frictional force on thepassage 132 and openings 136, 140 of the saddle 108 to resist movementof the first portion 116 within the saddle 108 and thereby lock the softanchor 104 in the deformed position and prevent the suture 112 fromslideably moving within the soft anchor 104.

Now referring to FIGS. 3, 4A, and 4B, alternative embodiments 200 and300 of the non-sliding suture construct 100 are illustrated. Thealternative embodiments 200, 300 include the same soft anchor 104 andsaddle 108 as described in relation to suture construct 100. Similar tosuture 112 of suture construct 100, non-sliding suture construct 200(FIG. 3) includes a suture 204 having a first portion 208 adjacent to afirst end 212 and a second portion 216 adjacent to a second end 220which is opposite the first end 212, and non-sliding suture construct300 (FIGS. 4A-4B) includes a suture 304 having a first portion 308adjacent to a first end 312 and a second portion 316 adjacent to asecond end 320 which is opposite the first end 312. To help distinguishbetween the first portion 208, 308 and the second portion 216, 316,which can be particularly helpful for a surgeon during surgery, thefirst portion 208, 308 and second portion 216, 316 can be provided withan identifying characteristic such as different colors or designs, forexample. The identifying characteristic may be the same as, or similarto, the identifying characteristics described in U.S. patent applicationSer. No. 13/791,014, assigned to Biomet Sports Medicine, which isincorporated by reference herein.

Referring specifically to FIG. 3, the first portion 208 and secondportion 216 may be provided with different colors, designs, and indicia.As illustrated in the figure, the first portion 208 may be a plainwhite, or other solid color, suture, while the second portion 216 mayinclude an identifier characteristic such as a color coating 224, or oneor more colored strands, on a portion of the suture 204. The suture 204may include an outer wall 228 formed from a plurality of strands (notillustrated) braided together. Each strand may further include aplurality of fibers (not illustrated) braided together to form thestrand. The plurality of fibers may be an all-white polyethylenematerial that is braided to form the plurality of strands. In otherembodiments, the plurality of fibers may also include one or morecolored strands woven into the all-white polyethylene material.

In an example embodiment, the second portion 216 may be coated with adye or other material that is known to adhere to the polyethylenematerial. The dye or other material may be of a contrasting color to theall-white polyethylene and therefore may provide the color coating 224on a portion of the suture 204. In some embodiments, the color coating224 may be applied to the entire second portion 216 (not illustrated).In other embodiments, the color coating 224 may be applied in specificlocations of the second portion 216 (for example, similar to the candycane stripe illustrated in FIG. 3), distinguishing the second portion216 from the first portion 208. In other embodiments, the second portion216 may include one or more colored strands to either form a stripedstrand or a strand of a different color from the first portion 208. Thedifferences between the first portion 208 and the second portion 216become more apparent when the suture 204 is threaded through the softanchor 104. The differences help to identify the direction of travel andcorresponding ends each of the first and second portions 208, 216. Thecolor 224 on only a portion of the suture 204 as described in relationto FIG. 3 may be further described in U.S. patent application Ser. No.13/791,014, assigned to Biomet Sports Medicine, LLC, which isincorporated by reference herein.

Referring specifically to FIGS. 4A and 4B, the first portion 308 andsecond portion 316 may be provided with different designs. The firstportion 308 may be a 16-strand hollow-core suture and may include anouter wall 324 formed from a plurality of strands braided together. Eachstrand may further include a plurality of fibers braided together toform the strand. The second portion 316 may be a 16-strand flat braidedribbon formed from the plurality of strands braided together. Eachstrand may further include the plurality of fibers braided together toform the strand. The round or cylindrical shape of the first portion 308is distinguished from the flat shape of the second portion 316 both bytouch and sight to assist the surgeon in distinguishing the firstportion 308 from the second portion 316. The embodiment described inrelation to FIGS. 4A and 4B may be further described in U.S. patentapplication Ser. No. 13/791,014, assigned to Biomet Sports Medicine,LLC, which is incorporated by reference herein.

When assembling the suture construct 300, the flat, second portion 316is threaded through the cylindrical, first portion 308 to form thesaddle 108. This embodiment may provide superior gripping capability dueto a higher frictional force between the flat, second portion 316 andthe wall of the passage 132 and the openings 136, 140 of the saddle 108.

The suture 304 may include a plurality of first portions 308 and secondportions 316 as best illustrated in FIG. 4A. When multiple firstportions 308 and second portions 316 are included, the first portions308 will not always be proximate to the first end 312 and the secondportions 316 will not always be proximate to the second end 320. If thesuture 304 includes the plurality of first portions 308 and secondportions 316, the first end 312 will be one of the first portion 308 andsecond portion 316 and the second end 320 will be the other of the firstportion 308 and the second portion 316 to distinguish the first end 316from the second end 320. Further, if the suture 304 includes theplurality of first portions 308 and second portions 316, the pluralityof first portions 308 and second portions 316 will be arranged such thatone of the plurality of second portions 316 is threaded through one ofthe plurality of first portions 308 to form the saddle 108.

Now referring to FIG. 5, another embodiment of a non-sliding sutureconstruct 400 is illustrated. The non-sliding suture construct 400operates similarly to the non-sliding suture constructs 100, 200, 300where the first portion 116 that is fed through the second portion 124to form the saddle 108 exerts a frictional force on the passage 132 andopenings 136, 140 of the saddle 108 to resist movement of the firstportion 116 within the saddle 108 and thereby lock the soft anchor 104in the deformed position and prevent the suture 112 from slid ablymoving within the soft anchor 104.

Suture construct 400 implements two sutures 112, 112′, two saddles108,108′, and a single soft anchor 104. FIG. 5 is formed by taking asuture construct similar to the suture construct 100 in FIG. 2 andthreading a first portion 116 of a second suture 112′ through the secondanchor opening 160 in the soft anchor 104, through the internal passage152, and out the first anchor opening 156 in the soft anchor 104. Thefirst portion 116′ is then threaded through a second portion 124′ of thesecond suture 112′ to form the second saddle 108′, similar to the saddle108 in suture construct 100. Usage of the suture construct 400 providesdoctors and/or surgeons with the availability of additional suture ends.It is understood that while only two sutures 112, 112′ with two saddles108, 108′ are threaded through the soft anchor 104, any number ofsutures having saddles may be utilized.

With additional reference to FIGS. 6-18, a method for implanting one ofthe non-sliding suture constructs 100, 200, 300, 400 in a bone 500 tosecure a tissue 504 to the bone 500 will now be described. Asillustrated, the bone 500 may be a humerus and the soft tissue 504 maybe a rotator cuff. The non-sliding suture construct 100, 200, 300, 400can be used to secure a torn rotator cuff or labrum in place. The bone500 includes a hard, outer cortical bone layer 508 and a softer, innercancellous bone layer 512.

For brevity and clarity, it is noted that the method of implanting oneof the non-sliding suture constructs 100, 200, 300, 400 in the bone 500to secure the tissue 504 to the bone 500 is described using non-slidingsuture construct 100. However, the method of implanting one of thenon-sliding suture constructs 100, 200. 300. 400 in the bone 500 tosecure the tissue 504 to the bone 500 may be performed using any of thenon-sliding suture constructs 100, 200, 300, 400 described herein, orusing any similar suture constructs known.

Now referring to FIG. 6, the suture construct 100 is loaded on aninsertion tool 516. The insertion tool 516 generally includes a body 520and a handle 524. The body 520 is an elongated rod that may becylindrical in shape. The body 520 is attached to the handle 524 at aproximal end 528 and includes a tip 532 having a plurality of peaks 536separated by a channel 540 at a distal end 544.

The handle 524 further includes a first channel 548 extending along alongitudinal axis of the handle 524 and a second channel 552 extendingradially around the handle 524. The handle 524 may further include atubular post 556 and cap 560 for securing the suture 112 to the handle524.

The insertion tool 516 may be the same or similar to any of theinsertion tools disclosed in “JuggerKnot Soft Anchor: Arthroscopic andMini-Open Rotator Cuff Repair Using JuggerKnot Soft Anchor—2.9 mm withALLthread Knotless Anchor Surgical Technique,” a publication produced byBiomet Sports Medicine and incorporated herein in its entirety. Theinsertion tool 516 may also be same or similar to any of the insertiontools disclosed in U.S. Patent Publication No. 2013/0144338, publishedon Jun. 6, 2013 and assigned to Biomet Sports Medicine, LLC, which isincorporated herein by reference.

The soft anchor 104 is positioned on the tip 532 of the insertion tool516 along the channel 540 and between the peaks 536. The suture 112extending from the soft anchor 104 is positioned parallel with andproximate to the body 520 and is received within the first channel 548in the handle 524. In an example embodiment, the suture 112 is securedto the handle 524 by wrapping the suture 112 around the first channel548 and/or the second channel 552 of the handle. In another embodiment,the suture 112 is secured to the handle 524 by threading the suture 112through a bore in the post 556. The suture is fixed within the post 556by threading or pressing the cap 560 on the end of the post 556 andcompressing the suture 112 between the post 556 and cap 560. Each ofthese methods of loading the suture construct 100 on the insertion tool516 is further disclosed and described in “JuggerKnot Soft Anchor:Arthroscopic and Mini-Open Rotator Cuff Repair Using JuggerKnot SoftAnchor—2.9 mm with ALLthread Knotless Anchor Surgical Technique,” apublication produced by Biomet Sports Medicine and U.S. PatentPublication No. 2013/0144338, published on Jun. 6, 2013 and assigned toBiomet Sports Medicine, LLC. The disclosures of each are incorporatedherein in their entireties.

As illustrated in FIGS. 7 and 8, a bone hole 564 is formed in the bone500 using any suitable device, such as a surgical drill. The bone hole564 is formed along a medial row of the bone 500 and proximate to thetissue 504 to be secured to the bone 500. To form the bone hole 564, aninsertion guide 568 is positioned at the desired angle and location onthe bone 500 as illustrated in FIG. 7. The insertion guide 568 is anelongated tubular rod having a bore 572 centered within the insertionguide 568 and extending along a longitudinal axis of the insertion guide568 from a first, distal end 576 to a second, proximal end 580 of theinsertion guide 568. The insertion guide 568 further extends through ahandle 584 positioned at the proximal end 580 of the insertion guide568. The insertion guide 568 may further include a window 588 proximateto the distal end 576 of the insertion guide 568 to provide viewingcapability into the bore 572. The insertion guide 568 may be furtherdescribed in “JuggerKnot Soft Anchor: Arthroscopic and Mini-Open RotatorCuff Repair Using JuggerKnot Soft Anchor—2.9 mm with ALLthread KnotlessAnchor Surgical Technique,” a publication produced by Biomet SportsMedicine and incorporated herein in its entirety.

Now referring specifically to FIG. 8, a bore formation tool 592, such asa surgical drill, is inserted into the bore 572 in the insertion guide568. In an example embodiment, the bore formation tool 592 may include adrill handle 596, a driving rod 600, and a reamer 604. The reamer 604 ispositioned on a distal end 608 of the bore formation tool 592, and thedrill handle 596 which drives the driving rod 600, and in effect thereamer 604, is positioned on a proximal end 612 of the bore formationtool 592. In another embodiment, the bore formation tool 592 may includea punch (not illustrated) on the distal end 608 of the bore formationtool 592 and a handle (not illustrated) configured for malleting on theproximal end 612 of the bore formation tool 592. The bore formation tool592 may be further described in “JuggerKnot Soft Anchor: Arthroscopicand Mini-Open Rotator Cuff Repair Using JuggerKnot Soft Anchor—2.9 mmwith ALLthread Knotless Anchor Surgical Technique,” a publicationproduced by Biomet Sports Medicine and incorporated herein in itsentirety.

The driving rod 600 and reamer 604 are inserted within the bore 572 ofthe insertion guide 568 and are engaged with the bone 500 to form thebone hole 564, The bore formation tool 592 is inserted into the bore 572until the drill handle 596 contacts the handle 584 of the insertionguide 568 indicating an appropriate depth of the bone hole 564 in thebone 500. At an appropriate depth, the bone hole 564 may traversethrough the cortical bone layer 508 and into the cancellous bone layer512. The window 588 in the insertion guide 568 may be additionallyhelpful in monitoring the depth of the bone hole 564, such as forviewing depth indicia indicated on the driving rod 600. The boreformation tool 592 is then removed from the insertion guide 568.

Now referring to FIGS. 9 and 10, the soft anchor 104 is deployed andsecured within the bone 500. The insertion tool 516, with the sutureconstruct 100 preloaded, is inserted into the bore 572 in the insertionguide 568. As illustrated in FIG. 9, the soft anchor 104 is insertedinto the bone hole 564 and positioned such that the first anchor end 144and the second anchor end 148 abut an undersurface 616 of the corticalbone layer 508 at opposite sides of the bone hole 564, which restrictsthe suture tail 164 from being pulled out from within the bone 500. Thesoft anchor 104 can be inserted using any suitable inserter, such asthose described herein. The Ser. No. 12/915,962 Application, which isincorporated by reference, provides additional disclosure for forming abone hole and implanting a flexible anchor. The additional disclosure ofthe Ser. No. 12/915,962 Application also applies to the forming of bonehole 564 and insertion of anchor 104 within the bone hole 564.

As illustrated in FIG. 10, the insertion tool 516 is partially removedfrom the bone hole 564 to pull back on the suture 112 and soft anchor104. This action will deform the soft anchor 104 from a first position(FIG. 9) to a second position (FIG. 10). When in the first position, thesoft anchor 104 may be a generally horseshoe-shaped or u-shapedconfiguration, and the suture 112 may be slideably movable relative tothe soft anchor 104. When in the second position, the soft anchor 104may be a generally bunched configuration, and the suture may be fixedrelative to the soft anchor 104.

Now referring to FIG. 11, the first and second suture ends 120, 128 arereleased from the insertion tool 516. In an example embodiment, thefirst and second suture ends 120, 128 are released by removing the cap560 from the post 556 and releasing the compression of the suture 112between the cap 560 and the post 556. In another embodiment, the firstand second suture ends 120, 128 are released by unwrapping the suture112 from the first and second channels 548, 552 (FIG. 6). Release of thesuture ends 120, 128 free the suture construct 100 from the insertiontool 516 and allow the insertion tool 516 to be removed from theinsertion guide 568.

Now referring to FIG. 12, the insertion tool 516 is removed from theinsertion guide 568, and the insertion guide 568 is removed from theouter surface of the bone 500. The first and second suture ends 120, 128are threaded back through the insertion guide 568 to free the insertionguide 568 from the suture construct 100 and the surface of the bone 500.As the insertion tool 516 and the insertion guide 568 are removed fromthe bone 500, tension is kept on the first and second ends 120, 128 ofthe suture 112 such that the soft anchor 104 remains deformed in thesecond position or configuration within the bone hole 564.

Now referring to FIG. 13, the saddle 108 is slideably moved along thesuture 112, or tightened, to a position within the bone hole 564proximate to the soft anchor 104. The first end 120 of the saddle 108 ispulled to tighten the suture 112 and reduce the size of the adjustableloop 142. As the size of the adjustable loop 142 decreases, the saddle108 is drawn into the bone hole 564, the second anchor end 148 abuts thefirst opening 136 in the saddle 108, and the saddle 108 compresses thesoft anchor 104 such that the soft anchor 104 further deforms.

The saddle 108 is inserted within the bone hole 564 until the secondopening 140 of the saddle 108 is at least flush with the surface of thebone 500. As the saddle 108 is tightened along the suture 112, the softanchor 104 continues to deform, or bunch, within the bone hole 564, Oncethe saddle 108 is proximate to the soft anchor 104 and the secondopening 140 of the saddle 108 is at least flush with the surface of thebone 500, the saddle 108 fixes the sutures 112 by applying staticfriction between the exterior surface of the suture 112 and the interiorsurface of the passage 132. The first portion 116 that is fed throughthe second portion 124 to form the saddle 108 exerts a frictional forceon the passage 132 and openings 136, 140 of the saddle 108 to resistmovement of the first portion 116 within the saddle 108 and thereby lockthe soft anchor 104 in the deformed position and prevent the suture 112from slideably moving within the soft anchor 104. The static frictionresults in an automatic lock that maintains tension on the suture 112 inthe soft anchor 104, retaining the soft anchor 104 in the deformed, orbunched, position. The saddle 108 locks movement of the suture 112relative to the soft anchor 104 such that the suture 112 cannot slipthrough the anchor 104.

Now referring to FIGS. 14 and 15, a plurality of suture constructs 100may be inserted medially, near an articular margin 620 of the humerus500 (FIG. 14). In an example embodiment, the first and second ends 120,128 of the plurality of suture constructs 100 are threaded through thetissue, or rotator cuff, 504 (FIG. 15). The tissue 504 is threaded alongthe suture 112 until proximal to the bone 500 at a position on thesuture 112 that is near the saddle 108 in the bone hole 564 of the bone500. This configuration is additionally illustrated in FIG. 17. Themethod of threading the first and second ends 120, 128 may beadditionally described in “JuggerKnot Soft Anchor: Arthroscopic andMini-Open Rotator Cuff Repair Using JuggerKnot Soft Anchor—2.9 mm withALLthread Knotless Anchor Surgical Technique,” a publication produced byBiomet Sports Medicine and incorporated herein in its entirety. In otherembodiments, the first and second ends 120, 128 of the plurality ofsuture constructs 100 may be passed around the tissue, or muscle, 504.

Since the saddle 108 was tightened against the soft anchor 104preventing the suture 112 within the soft anchor 104 from slidingrelative to the soft anchor 104, it is unnecessary to fix the sutures ona top side 624 of the tissue 504 as previously practiced. In otherwords, the knotless sutures are threaded from the soft anchor 104,through the tissue 504, and are affixed to secondary anchors in the bone500, as further described below. No knots are tied in the sutures 112,unless a knot is used to affix the suture 112 to the secondary anchor628, and in that instance, a knot is only placed in the suture 112 toaffix the suture to the secondary anchor 628—the suture 112 extends fromthe soft anchor 104, through the tissue 504, and to the secondary anchor628 without forming any knots between the soft anchor 104 and thesecondary anchor 628. A plurality of knotless sutures are tensioned onthe top side 624 of the tissue 504 to create a web of suture over thetissue 504. Restraining the suture 112 within the soft anchor 104 beforethreading the suture 112 through the tissue 504 prevents any potentialtissue strangulation from knotting or fixing the suture on the top side624 of the tissue 504.

Now referring to FIGS. 16A-16B, the sutures 112 are threaded through (orpassed around) the tissue 504 are threaded onto a secondary anchor 628using a passing wire tool 632. The sutures 112 are threaded through aloop 636 in the passing wire tool 632 as shown in FIG. 16A, and pulledthrough a tunnel 640 in the secondary anchor 628. The passing wire tool632 continues to direct the sutures 112 through a passage 644 in asecondary anchor inserter tool 648 to load the secondary anchor 628 andsuture 112 on the secondary anchor inserter tool 648. Furtherdescription of the secondary anchor insertion tool 648 and the method ofloading the secondary anchor 628 and the suture 112 in the tool can befound in “JuggerKnot Soft Anchor: Arthroscopic and Mini-Open RotatorCuff Repair Using JuggerKnot Soft Anchor—2.9 mm with ALLthread KnotlessAnchor Surgical Technique,” a publication produced by Biomet SportsMedicine and incorporated herein in its entirety.

Now referring to FIG. 17, one or a plurality of secondary anchor bores,or lateral portals, 652 is formed in a lateral row 656 of the humerus500. The secondary anchor bores 652 may be formed by punching,malleting, drilling, any method discussed in the present disclosure, orany other known method. The secondary anchor insertion tool 648containing the secondary anchor 628 and suture 112 is inserted in thelateral portal 652 and positioned such that the secondary anchor 628 isat the same angle of insertion as the soft anchor 104 and saddle 108.The secondary anchor insertion tool 648 containing the secondary anchor628 may be malleted to assist in inserting the secondary anchor 628within the lateral portal 652. While maintaining tension on the suture,the secondary anchor 628 is pressed the remainder of the distance intothe lateral portal 652. The secondary anchor 628 may also be firmlyscrewed into the lateral portal 652 until the secondary anchor 628 isflush with the bone 500. Once the secondary anchor 628 is flush with thebone 500, the excess suture may be removed by cutting. The method ofinserting the secondary anchors 628 into the lateral portals 652 may befurther described in “JuggerKnot Soft Anchor: Arthroscopic and Mini-OpenRotator Cuff Repair Using JuggerKnot Soft Anchor—2.9 mm with ALLthreadKnotless Anchor Surgical Technique,” a publication produced by BiometSports Medicine and incorporated herein in its entirety.

Now referring to FIG. 18, a plurality of secondary anchors 628 may beinserted into a plurality of lateral portals 652 formed in the lateralrow 656. The use of a plurality of suture constructs 100, 200, 300 (orthe use of suture constructs 400) with a plurality of secondary anchors628 forms a web 660 of sutures retaining the tissue 504 against the bone500.

As previously described, the suture construct 100, 200, 300, 400 allowsa first tissue to be coupled to a second tissue without the need to tieknots, which makes surgery, particularly arthroscopic procedures, easierand faster. In some instances, by eliminating the need to tie knots thesuture construct 100, 200, 300, 400 may make the connection betweenfirst and second tissues more reliable. The suture 112 is passed throughor around tissue, particularly during arthroscopic procedures. Thesuture 112 may be passed through or around the tissue before or afterthe anchor 104 has been implanted, which can further expedite and makearthroscopic procedures less complicated.

Some or all of the suture construct 100, 200, 300, 400, the insertionguide 568, the bore formation tool 592, the insertion tool 516, thepassing wire tool 632, the secondary anchor inserter tool 648, and thesecondary anchor 628 may be included in a kit or a system for implantinga non-slip suture construct for coupling tissue. The lengths of thevarious tools 516, 592 may be designed with respect to the insertionguide 568 as a method of controlling the depth of the tool within thetissue. Alternatively, or in addition, the various tools 516, 592 and/orinsertion guide 568 may include depth control indicia (not illustrated)for monitoring the depth of the instrument within the tissue.

The foregoing description of the embodiments has been provided forpurposes of illustration and description. It is not intended to beexhaustive or to limit the disclosure. Individual elements or featuresof a particular embodiment are generally not limited to that particularembodiment, but, where applicable, are interchangeable and can be usedin a selected embodiment, even if not specifically shown or described.The same may also be varied in many ways. Such variations are not to beregarded as a departure from the disclosure, and all such modificationsare intended to be included within the scope of the disclosure.

1.-7. (canceled)
 8. A suture anchor system, comprising: a soft anchorthat is positionable in a bone hole and deformable from a firstcondition to a second condition; and an adjustable suture construct thatincludes a suture with a first free end and a second free end, the firstfree end extending: (i) into the suture through a first opening in anouter wall of the suture; (ii) longitudinally within the suture along afirst longitudinal passage in the suture; and (iii) out of the suturethrough a second opening in the outer wall of the suture to form anadjustable loop portion of the adjustable suture construct, wherein thesoft anchor is received on the adjustable loop portion of the adjustablesuture construct, wherein the adjustable loop portion of the adjustablesuture construct comprises a first length of suture formed out of ahollow-core braided suture material, wherein the suture comprises asecond length of suture formed out of a flat braided suture material,the second length of suture located along the suture between the secondfree end of the suture and the second opening in the outer wall of thesuture.
 9. The suture anchor system of claim 8, wherein the soft anchorcomprises a tube.
 10. The suture anchor system of claim 8, wherein thesoft anchor being received on the adjustable loop portion includessuture of the adjustable loop portion extending longitudinally withinthe soft anchor along an internal longitudinal passage in the softanchor.
 11. The suture anchor system of claim 8, wherein the soft anchoris formed with a suture material.
 12. The suture anchor system of claim8 further comprising a second anchor connected to the suture.
 13. Thesuture anchor system of claim 12, wherein the second anchor is coupledto the soft anchor with a section of the suture that is free of knots.14. The suture anchor system of claim 8, wherein the second free end ofthe suture is formed out of a flat braided suture material.
 15. A sutureconstruct, comprising: a single length of suture that includes a firstend portion, a second end portion and a first intermediate portion whichare all formed out of a hollow-core braided suture material, wherein thefirst intermediate portion is located along the single length of suturebetween the first end portion and the second end portion, and whereinthe single length of suture further includes a second intermediateportion and a third intermediate portion which are both formed out of aflat braided suture material, the second intermediate portion locatedalong the single length of suture between the first end portion and thefirst intermediate portion, the third intermediate portion located alongthe single length of suture between the second end portion and the firstintermediate portion.
 16. The suture construct of claim 15 incombination with a soft tubular anchor received on the firstintermediate portion of the single length of suture.
 17. The sutureconstruct of claim 16, wherein the soft tubular anchor is formed with asuture material.
 18. The suture construct of claim 16, wherein the softtubular anchor being received on the first intermediate portion of thesingle length of suture includes suture of the first intermediateportion extending longitudinally within the soft tubular anchor along aninternal longitudinal passage in the soft tubular anchor.
 19. The sutureconstruct of claim 18, wherein suture of the first intermediate portionextends: (i) into the soft tubular anchor through a first Opening in anouter wall of the soft tubular anchor; (ii) longitudinally within thesoft tubular anchor along the internal longitudinal passage in the softtubular anchor; and (iii) out of the soft tubular anchor through asecond opening in the outer wall of the soft tubular anchor.
 20. Asuture anchor system, comprising: a soft anchor that is positionable ina bone hole and deformable from a first condition to a second condition;and an adjustable suture construct that includes a suture with a firstfree end and a second free end, the first free end extending: (i) intothe suture through a first opening in an outer wall of the suture; (ii)longitudinally within the suture along a first longitudinal passage inthe suture; (iii) and out of the suture through a second opening in theouter wall of the suture to form an adjustable loop portion of theadjustable suture construct, wherein the soft anchor is received on theadjustable loop portion of the adjustable suture construct, wherein theouter wall of the suture along the first longitudinal passage is formedout of a hollow-core braided suture material, wherein a length of thesuture between the second free end of the suture and the second openingin the outer wall of the suture is formed out of a flat braided suturematerial.
 21. The suture anchor system of claim 20, wherein the softanchor comprises a tube.
 22. The suture anchor system of claim 20,wherein the soft anchor being received on the adjustable loop portionincludes suture of the adjustable loop portion extending longitudinallywithin the soft anchor along an internal longitudinal passage in thesoft anchor.
 23. The suture anchor system of claim 20, wherein the softanchor is formed with a suture material.
 24. The suture anchor system ofclaim 20 further comprising a second anchor connected to the suture. 25.The suture anchor system of claim 24, wherein the second anchor iscoupled to the soft anchor with a section of the suture that is free ofknots.
 26. The suture anchor system of claim 20, wherein the second freeend of the suture s formed out of a flat braided suture material. 27.The suture anchor system of claim 20 in combination with an inserter,wherein the soft anchor is mounted on a distal end of the inserter withat least part of the adjustable suture construct extending back alongthe inserter in a proximal direction.